The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.

The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency (Cronbach's alpha=0.91) and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.

Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.

Drug: Eszopiclone

Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.

Other Name: Lunesta

Placebo Comparator: Placebo Group

Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study.

Drug: Placebo

Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study

Detailed Description:

The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.

Eligibility

Ages Eligible for Study:

18 Years to 64 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Be between the ages of 18 to 64

Meet DSM-IV criteria for schizophrenia or schizoaffective disorder

Sleep difficulties at least 2x per week in the preceding month

Be on a stable dose of antipsychotic medication

Symptomatically stable in the last 2 months

English speaking.

Exclusion Criteria:

Meet criteria for current alcohol or other substance dependence

A history of dementia, mental retardation or other neurological disorder

Not capable of giving informed consent for participation in this study.

Ongoing pregnancy

Known sensitivity to zopiclone.

Insomnia associated with medical disorders likely to impair sleep.

Use of any medication that affects sleep/wake function (other than antipsychotic medication), within the past 2 weeks or within a time period that is less than 7 half-lives since last use of the medication.

Lack of sleep benefit from previous adequate eszopiclone treatment

History of clinically significant hepatic impairment.

Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645944